RESPONSIBILITIES:

　　• This role is of Quality & Compliance Manager for Commercial Quality in Japan supporting the Japan Commercial Quality & Compliance Leader.

　　• Responsible for implementing the Quality and Regulatory Compliance requirements; driving compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures etc.

　　• Support the maintenance of the QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.

　　• Support Local Quality leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.

　　• Interface with Tech Services and Legal Manufacturers on Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups. Proactively reviewing product complaints and address the trends in a timely manner.

　　• Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.

　　• Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.

　　• Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)

　　• Ensuring implementation of effective CAPA program across operational site.

　　• Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).

　　• Review Changes, Deviations, Investigations, Market Complaints & CAPA.

　　• Responsible for the Quality Control program for imported products that are distributed in the market

　　o Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.

　　• Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.

　　• Continuously drive for compliance with Abbott quality standards and regulatory requirements.

　　• Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.

　　• Coordinate and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.

　　• Responsible for coordination and management of site Quality metric tracking, trending and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.

　　• Responsible for supporting for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial Quality lead.

　　BASIC QUALIFICATIONS | EDUCATION:

　　• Bachelor Degree in Pharmacy/Science/Engineering.

　　• Must have been employed in the Medical Device/Pharmaceutical /IVD industry for a minimum of 6 years.

　　• Minimum of 8 years’ experience in Quality Assurance and /or Compliance in a regulated industry.

　　• Ability to effectively communicate in Japanese and English.

　　COMPETENCIES:

　　• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.

　　• Strong ability to negotiate with stakeholders.

　　• Able to manage multiple priorities.

　　• Superior attention to accuracy and details.

　　• Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.

　　• Strong knowledge of relevant medical device industry regulations for quality systems and compliance.

　　• Experience in conducting and handling audits and inspections.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]